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Interactive Robot on Pre-operative Anxiety and Fear of Children

NCT ID: NCT06148844

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2023-11-18

Brief Summary

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The aim of this study is to determine the effect of preoperative preparation applied with an interactive robot on children's preoperative anxiety and fear levels.

Hypothesis;

H1: Pre-operative preparation with an interactive robot has an effect on the anxiety level of children H2: Pre-operative preparation with an interactive robot has an effect on the fear level of children H3: The anxiety levels of children in intervention and control groups are different after the pre-operative preparation H4: The fear levels of children in intervention and control groups are different after the pre-operative preparation

Detailed Description

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The use of interactive robots can be preferred as a remarkable method of communication with hospitalized children. In this way, it will be easier for the children to understand the procedure and they will be able to communicate easily with healthcare professionals. Children may develop a sense of control and the level of anxiety and fear they experience may decrease when they interact with robots. It is reported in the literature that children show more interest in robots than they do in adults. In addition, children see social robots as living creatures, not as devices, and children who spend time with them for a long time adopt them as friends. In a study, a social humanoid robot was used to prepare children aged 7-12 (n = 11) regarding the cancer diagnosis process and interventional procedures. According to the results of the study, the children's stress, depression, and anger during the treatment decreased significantly. Interactive robots positively affect postoperative mobilization in children undergoing day surgery and reduce the anxiety level of children before mobilization. As a result, it may be easier for children to cope with stress with the use of interactive and humanoid robots. Also, interactive robots can facilitate cooperation between the child and the nurse by playing an intermediary role in communication with children. Determining the effects of interactive robots on children by using them before the surgical procedure is important to ensure the active participation of children in the surgical process in pediatric surgery clinics. It is thought that this research is important in terms of interventions which appropriate to the supportive care role of nurses and will contribute to the literature.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two group with conventional therapy control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Control group will receive conventional pre-operative preparation and intervention group will receive pre-operative preparation designed with interactive robot by researchers

Study Groups

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Control Group

The routine preparation procedure in this group in the hospital will be applied by the nurses responsible for preoperative preparation. After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interactive robot group

In addition to the routine preparation procedure interactive robot will be used to preparation as a therapeutic approach. The interactive robot will accompany to the child the preparation for the surgery. Then, the features of the interactive robot will be explained to the children and parents and it will be introduced to the children. The interactive robot will meet the child with its speech feature and the robot will accompany to child to the operating room entrance. The child will be informed that he/she can request the interactive robot to follow him/her if he/she wishes. The child will be transferred to the operating room accompanied by the nurse, researcher and robot. After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels.

Group Type EXPERIMENTAL

interactive robot group

Intervention Type OTHER

Intervention group will receive one day pre-operative preparation intervention applied by researcher. Preparation will be 30-40 minutes long

Interventions

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interactive robot group

Intervention group will receive one day pre-operative preparation intervention applied by researcher. Preparation will be 30-40 minutes long

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Those between the ages of 5-10,
* having planned day surgery,
* scheduled for general anesthesia
* have not had surgery before,
* Those who can speak Turkish

Exclusion Criteria

* Children have mental-cognitive problems,
* Children have hearing, vision and/or speech disabilities
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Responsible Party

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Tuba Arpacı

Asisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuba ARPACI, PhD

Role: PRINCIPAL_INVESTIGATOR

Karamanoğlu Mehmetbey University

Locations

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Karaman Education and Research Hospital

Karaman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KMU-SBF-TA-01

Identifier Type: -

Identifier Source: org_study_id